Servier announces that topline results from the GRAND CANYON study did not meet the primary endpoint, with no statistically significant benefit on the North Star Ambulatory Assessment (NSAA). Secondary endpoints also were not met. The study, an 18-month global placebo-controlled trial evaluating the effect of sevasemten in Becker muscular dystrophy (BMD), demonstrated a continued favorable safety and tolerability profile.
The results of the pivotal GRAND CANYON study are not aligned with certain findings observed in prior clinical studies, including the Phase 2 CANYON study. Servier is conducting a comprehensive analysis of the GRAND CANYON study dataset, together with relevant prior clinical data, to better understand and further characterize the study findings.
Full results will be presented in the future.
Servier is grateful to all the trial participants, patients and caregivers, who participated in the clinical trials, as well as the investigators and study teams and internal teams whose commitment made this study possible.
Aligned with its mission to respond to patients’ unmet needs, Servier remains fully committed to driving rare neurology innovations to patients.